International Regulatory Affairs Specialist (Romania, Hungary, Bulgaria)

Grindeks is the leading pharmaceutical manufacturer in Baltic States, headquartered in Riga, Latvia and operating since 1946. Grindeks Group consists of JSC Grindeks and its subsidiaries.

We are looking for a dedicated and experienced International Regulatory Affairs Specialist to join our dynamic team and help navigate the complex regulatory landscape.

We are looking for International Regulatory affairs specialist locally in Romania, Bulgaria and Hungary.

Your main responsibilities will involve:

• Registration of generic medicinal products in accordance with national regulations of the USA, Canada, Australia.
• Communication with state authorities during the registration process.
• Supervision and maintenance of up-to-date registration documentation in the post-registration period: variations, renewals.
• Responsibility for the transfer of registration (MAH transfer) within implementation timelines.
• Knowledge and orientation in eCTD format.
• Close cooperation with Headquarter company management, local persons, pharmacovigilance, quality, and logistics departments.
• Coordinate where applicable the translations for SmPC, product labeling, artwork and patient information.
• Establish and enhance relationships and interactions with Regulatory Authorities.
• Keep records and files of Regulatory activities and databases.
• Monitoring changes in legislation and regulations and ensuring their implementation in the company.

You will excel if you have:

• University Degree in Chemistry or Pharmacy. Advanced degree preferred.
• Minimum of 2 years of experience in regulatory affairs within the pharmaceutical industry.
• In-depth understanding of regional and global regulatory requirements for pharmaceuticals. Experience with FDA regulations, Health Canada, TGA guidelines and other international regulatory standards are strongly preferred.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a team environment.
• Exceptional attention to detail and organisational skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.
• Proficiency in Microsoft Office (e.g., Word, Excel, Outlook).

What we offer:

• Unique opportunity to join the company in very exciting phase of business growth
• Opportunity to improve the quality of life for people worldwide by providing them simple and innovative solutions that improve their health
• Extensive motivation program
• Dynamic work environment
• Career development opportunities, professional as well as personal growth

Make health your habit!